Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion
- Conditions
- Lumbar Disc DiseaseLumbar Disc HerniationLumbar Spinal StenosisLumbar Spondylolisthesis
- Interventions
- Registration Number
- NCT03745040
- Lead Sponsor
- Allina Health System
- Brief Summary
This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.
- Detailed Description
This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug. It is a prospective, randomized clinical trial with two cohorts: Group A: standard of care (SOC) plus liposomal bupivacaine (n=30) and Group B: SOC (n=30). All subjects will undergo open single-level posterior decompression and instrumented fusion for degenerative spondylolisthesis. The surgery is not an experimental procedure. Prior to closing the surgical wound, liposomal bupivacaine will be administered to Group A. The administration of the drug is a study procedure, but note that this is an indicated use of the drug. Postoperatively, subjects will be assessed for pain and opioid consumption. The investigator's hypothesis for statistical analysis is that there will be a 30% decrease in pain medication requirement for the experimental group (Group A: Liposomal bupivacaine ) versus the control group (Group B: No Liposomal bupivacaine).
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 60
- Has a primary diagnosis of single-level lumbar stenosis, disc herniation, and/or spondylolisthesis excluding degenerative disc disease
- Receives open, one-level posterior spinal fusion
- Is opioid-tolerant. Opioid tolerant patients are receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.
- Experienced intraoperative complications (i.e., a dural tear or durotomy). Intra- and post-operative data will be excluded from the analysis for these patients.
- Has severe liver disease. Bupivacaine is primarily metabolized in the liver via conjugation with glucuronic acid. Patients with liver disease, especially severe disease may be more susceptible to toxicity.
- Has severe renal disease. Bupivacaine and the metabolite are primarily excreted by the kidneys. Excretion can be significantly changed by urinary perfusion, the presence of renal disease, factors affecting urinary pH, and renal blood flow
- Is less than 18 years old.
- Is pregnant.
- Cannot read and speak English.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: Exparel Liposomal bupivacaine Standard of Care plus Liposomal bupivacaine (Exparel®). Dosage: Exparel® 20 mL single use vial, 1.3% (13.3 mg/mL), Maximum dose of 266 mg (20 mL). Frequency: Single intraoperative administration
- Primary Outcome Measures
Name Time Method Change in Visual Analog Pain Scores Through study completion, an average of 2.5 days Change in Visual Analog Pain Scores over time; respondents report pain at incision site and at drain site on a scale of No pain (0) to Intolerable pain (10).
- Secondary Outcome Measures
Name Time Method Total Opioid Consumption Through study completion, an average of 2.5 days Total postsurgical opioid consumption in morphine equivalents
Patient Cost of In-Hospital Stay Through study completion, an average of 2.5 days Total combined cost in dollars of hospital room, drugs, laboratory tests, physical therapy, and respiratory therapy
Discomfort Through study completion, an average of 2.5 days Overall Benefit of Analgesia Score. Respondents complete seven questions, each with a score of 0 (minimal or not at all) to 4 (maximum or very much); the total OBAS ranges between 0 (complete relief of pain) and 28 (no benefit).
Length of Stay Through study completion, an average of 2.5 days Number of days in the hospital
Number of Participants with Pain Through study completion, an average of 2.5 days Proportion of pain free subjects, an average of 2.5 days
Number of Opioid-related Adverse Events Through study completion, an average of 2.5 days Average number of opioid-related adverse events per patient
Trial Locations
- Locations (2)
Abbott Northwestern Hospital, Allina Health System
🇺🇸Minneapolis, Minnesota, United States
United Hospital, Allina Health System
🇺🇸Saint Paul, Minnesota, United States